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510(k) K863913

THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT by Diagnostic Products Corp. — Product Code DOE

K863913 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT". The FDA issued a decision of Substantially Equivalent on March 19, 1987. The device falls under product code DOE (Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.), a Class II device regulated under 21 CFR 862.3640. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1987
Date Received
October 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code DOE

  • K010080 — INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST (May 29, 2001)
  • K010079 — INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST (May 29, 2001)
  • K011011 — LIVESURE MORPHINE SCREEN TEST (April 13, 2001)
  • K002418 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AN (November 22, 2000)
  • K951319 — ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 (June 1, 1995)
  • K935055 — ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) (August 9, 1994)
  • K933572 — URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (April 6, 1994)
  • K881102 — MICROMEDIC MORPHINE RIA KIT (June 24, 1988)
  • K864168 — MORPHINE ROCHE (R) EIA TEST (March 16, 1987)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)

FDA data resources